RECRUITING

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.

Official Title

Impact of Observation Versus Treatment on The Psychiatric and Mental Outcomes of Patients With Unruptured Intracranial Aneurysms

Quick Facts

Study Start:2023-12-01
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06123325

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unruptured intracranial aneurysms (UIA)
  2. * mRS scores between 0-1
  3. * Observation Group: All patients with UIAs that are eligible for conservative management.
  4. 1. Specific locations that are not good candidates for interventional treatment, such as cavernous internal carotid artery and very distally located aneurysms.
  5. 2. Aneurysm size (largest dimension) is less than 4 mm.
  6. * Treatment Group: All Patients with UIAs that are decided to be treated either with endovascular or microsurgical treatments due to several reasons, such as aneurysm size above 4 mm, patient's decision.
  1. * Prior history of intracranial hemorrhage.
  2. * Prior history of intracranial aneurysm
  3. * Severe comorbidities that impact the mental health of the patients, such severe psychiatric disease, and chronic end stage diseases.

Contacts and Locations

Study Contact

Muhammed Amir Essibayi, MD
CONTACT
718-920-7498
muhammedamir.essibayi@einsteinmed.edu
Genesis Liriano, MD
CONTACT
718-920-2469
gliriano@montefiore.org

Principal Investigator

David J Altschul, MD
PRINCIPAL_INVESTIGATOR
Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • David J Altschul, MD, PRINCIPAL_INVESTIGATOR, Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2026-03

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Cerebral aneurysm
  • Anxiety
  • Depression
  • Endovascular
  • Clipping

Additional Relevant MeSH Terms

  • Anxiety Depression
  • Aneurysm Cerebral
  • Mental Health Wellness 1